India’s drug regulator has granted regular market approval to coronavirus vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, Union Health Minister Mansukh Mandaviya said on Thursday.
“The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis,” the minister wrote in a tweet.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019, according to PTI.
On January 20, the subject expert panel on Covid-19 vaccines had recommended to the Central Drugs Standard Control Organisation that Covishield and Covaxin be granted regular market approval.
Covishield and Covaxin have been available in India since January last year under an emergency use authorisation from the drug regulator. An emergency use authorisation is granted during public health emergencies, based on results of clinical trials.
The lifting of the emergency use authorisation label effectively makes availability of vaccines easier and provide an opportunity for its entry into the distribution channel.
With the vaccines getting the approval of the drug regulator, the Covishield and Covaxin shots may soon be available in smaller private clinics unless the government decides to continue with the existing system of immunisation. It is still expected to take some time before consumers could buy the vaccines from retail outlets.
Unidentified officials told PTI on Thursday that the two vaccines will now be available in private clinics at pre-decided rates and people can buy them. However, the authorities have not issued an official statement to confirm this.
Both vaccines were granted emergency use authorisation on January 3.
India has so far administered 1,64,26,11,899 vaccine doses, according to data on CoWin portal. As many as 69,64,45,284 people have received both the shots. Also, 97,93,066 booster shots have been administered.